Karen Simmons

Testing for toxin burden – quality of data is essential

Accuracy matters, really matters, when test data must be trustworthy. It is vitally important when the sample is human blood. The test must also be reproducible when it is done in different laboratories. For blood testing, there is an additional challenge: the standard sampling involves venous blood drawn into multiple 6000 microliter tubes by a phlebotomist in a clinic using a needle and syringe. Blood draw is a painful, difficult and sometimes impossible struggle when it comes to autistic children and the aging. In addition, toxin burden tests are not regulated by the FDA as clinical tests: quality of test data among analytical labs vary widely. The standard toxin measurement instrument, the GC-MS (gas chromatography – mass spectrometer) has inherent limitations in terms of accuracy and precision.

Scientists currently believe environmental exposure is the causal factor for 50% to 70% of non-communicable diseases. Since World War II, over 80,000 chemicals have been created by the industry. Today, a barrage of chemicals in everything we grow, touch, play with, bite on, eat, drink and breath adversely affect health and well-being of humans. Little or no neurotoxicity data on these chemicals are available. Some chemicals are known to bioaccumulate and linger in the body. Many chemicals are very toxic, reproductively disruptive and harmful in many ways even at very low amounts.. Blood testing studies done by AIT and others have shown multiple chemical pollutants exist in the majority of populations around the world. A few dozen potent chemicals have been banned but those constitute only the tip of the iceberg.

Biomedical researchers are also concerned about the amplified health impact and damage from exposure to multiple toxins.

AITs transformative tests were used in a blinded and control-compared in a two-year clinical study to demonstrate the impact of exposure to toxins, particularly to environmental pollutants, as a causal factor affecting the onset and progression of autism, The study results, published in scientific journals, laid the groundwork for two emerging paradigms: a) children with autism experience a range of environmental influence from post-birth interactions with toxins that impact their health trajectories, b) lives of these children can be improved with practical and safe interventions guided by these blood biomarker tests.

AIT created a new testing Platform that significantly improves accuracy, precision and eliminates false positives. AIT automated these tests to achieve productivity and seamless transfer to other labs.

The company’s other invention enabled blood-biomarker tests requiring only a drop of blood that can be spotted and dried on an absorbent-filter spots encased in a card. AIT is currently developing a kit involving Quantitative Dried Blood Spot (QDBS) cards that are used to collect a drop of blood done at home. Shipping tubes from a blood draw is extraordinarily expensive because of biohazard containment regulations and requires cold-packs with dry-ice to minimize sample degradation. Dried blood is stable and non-hazardous: QDBS cards can be mailed directly to the laboratory via ordinary mail.

AIT plans to produce inexpensive blood-biomarker tests and make them available to the autism community as QDBS kits. Based on previous clinical studies, the company believes early QDBS testing will positively impact health trajectories and improve quality of lives of autistic children.